BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇵🇹 Portugal

    Deep Capsule® (Deep Capsule US)

    K Number: K250655 · Decision Mar 12, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    372

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Deep Capsule® (Deep Capsule US)
    K Number
    K250655
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Digestaid - Artificial Intelligence Development SA
    Date Received
    March 5, 2025
    Decision Date
    March 12, 2026
    Product Code
    QZF
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QZF Gastrointestinal Capsule Endoscopy Analysis Software Device

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QZF), ordered by most recent decision date.

    NaviCam ProScan

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all